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| ID | Type | Description | Link |
|---|---|---|---|
| U24DK061730 | U.S. NIH Grant/Contract | View source | |
| U01DK061732 | U.S. NIH Grant/Contract | View source | |
| U01DK061713 | U.S. NIH Grant/Contract | View source | |
| U01DK061737 | U.S. NIH Grant/Contract | View source | |
| U01DK061728 | U.S. NIH Grant/Contract | View source | |
| U01DK061718 | U.S. NIH Grant/Contract | View source | |
| U01DK061734 | U.S. NIH Grant/Contract | View source | |
| U01DK061738 | U.S. NIH Grant/Contract | View source | |
| U01DK061731 | U.S. NIH Grant/Contract | View source | |
| IRB00240822 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Liver Institute Northwest | UNKNOWN |
| Indiana University | OTHER |
| St. Louis University |
Not provided
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This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units (IU), 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks. The primary objective of the study is to determine the minimum effective dose of Vitamin E (d-alpha-tocopherol) based upon relative change in alanine aminotransferase (ALT) from baseline to 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E, 200 IU | Active Comparator | 200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
|
| Vitamin E, 400 IU | Active Comparator | 400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
|
| Vitamin E, 800 IU | Active Comparator | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
|
| Placebo | Placebo Comparator | matching placebo taken once daily with breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E | Drug | Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks | Percent change from baseline to 24 weeks relative to baseline measure of ALT. | Baseline to 24 weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks | Normalization of ALT (U/L) is defined as a decrease in ALT to less than or equal to the ULN at the 24 week visit among participants who had an ALT value greater than ULN at baseline. Values for upper limits of normal (ULN) are defined at each clinical center per institutional guidelines. | Baseline to 24 weeks (end of treatment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Concurrent or prior use (within 90 days) of vitamin E supplements in excess of 40 IU/day
Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day (~1.5 drinks/day) (> 10.5 drinks per week) in females and more than 30 g/day (~2 drinks/day) (>14 drinks per week) in males, respectively. One "standard" drink (or one alcoholic drink equivalent) contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits).
Inability to reliably quantify alcohol consumption based upon local study physician judgment
Continued use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization
Current use of anticoagulation therapy (not including antiplatelet agents such as aspirin or clopidogrel)
Platelet count below 150,000 /mm3 within 90 days of randomization
History of condition(s) that cause increased risk of bleeding, including hemophilia A, hemophilia B, von Willebrand disease, or other clotting factor deficiencies.
Prior or planned (during the study period) bariatric surgery (eg, gastroplasty, roux-en-Y gastric bypass)
Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to randomization
Clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities:
Evidence of other forms of chronic liver disease:
Serum alanine aminotransferase (ALT) greater than 400 U/L within 90 days of randomization
Moderate or severe renal impairment (serum creatinine ≥ 2.0 mg/dL or eGFR < 60 mg/mL/1.73m2)
History of biliary diversion or evidence of current biliary obstruction
Known positivity for Human Immunodeficiency Virus (HIV) infection
Active, serious medical disease with likely life expectancy less than 5 years
Active substance abuse including inhaled or injection drugs in the year prior to screening
Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use ≥ 1 effective form(s) of birth control during the trial, breast feeding
Current use of medications that may impact the absorption of fat-soluble vitamins (i.e. orlistat or cholestyramine)
Pre-existing history of fat malabsorption
Males at high risk of prostate cancer, including:
Participation in an IND trial in the 30 days before randomization
Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study, including inability to swallow treatment capsules
Failure or inability to give informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Arun Sanyal, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92103 | United States | ||
| University of Southern California |
Not provided
| Label | URL |
|---|---|
| Nonalcoholic Steatohepatitis Clinical Research Network Centers | View source |
| The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | View source |
Not provided
This study will comply with the 2013 NIH Data Sharing Policy. Results and information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository within two years of the date that the database is locked for analysis (interventional studies, primary and secondary outcomes).
Data from this study may be requested from the NIDDK Central Repository (https://www.niddkrepository.org/search/study/) within two years of the date the database is locked for analysis (interventional studies, primary and secondary outcomes)
Apply through the NIDDK Central Repository:
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin E, 200 IU | 200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| FG001 | Vitamin E, 400 IU | 400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| FG002 | Vitamin E, 800 IU | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| FG003 | Placebo | matching placebo taken once daily with breakfast Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adult participants randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin E, 200 IU | 200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| BG001 | Vitamin E, 400 IU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks | Percent change from baseline to 24 weeks relative to baseline measure of ALT. | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | % change | Baseline to 24 weeks (end of treatment) |
|
48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin E, 200 IU | 200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arun J. Sanyal, MD | Virginia Commonwealth University-Medical College of Virginia Campus | (804) 828-7811 | arun.sanyal@vcuhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2022 | Jan 27, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 25, 2022 | Feb 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| OTHER |
| University of California, San Diego | OTHER |
| University of Southern California | OTHER |
| University of California, San Francisco | OTHER |
| Virginia Commonwealth University | OTHER |
| The Cleveland Clinic | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
multicenter, randomized, double masked, placebo-controlled, parallel treatment groups
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|
| Placebo | Drug | Participants will take a placebo vitamin E capsule daily for 24 weeks |
|
| Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline | ALT value in U/L | Baseline to 24 weeks (end of treatment) |
| Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline | AST value in U/L | Baseline to 24 weeks (end of treatment) |
| Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function | CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat. | Baseline to24 weeks (end of treatment) |
| Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan® | Fibroscan® measures stiffness in kiloPascal's (kPa) and ranges from 2 to 75. Normal range of FibroScan is between 2 to 7 kPa, and the average normal result is 5.3kPa. Higher kPa means more stiffness (scarring). | Baseline to 24 weeks (end of treatment) |
| Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks | GGT is measured in U/L | Baseline to 24 weeks (end of treatment) |
| Mean Change in Glucose From Baseline to 24 Weeks | Fasting glucose measured in mg/dL | Baseline to 24 weeks (end of treatment) |
| Mean Change in Weight From Baseline to 24 Weeks | Weight measured in kilograms (kg) | Baseline to 24 weeks (end of treatment) |
| Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks | BMI is reported in kg/m-squared | Baseline to 24 weeks (end of treatment) |
| Mean Change in Waist Circumference From Baseline to 24 Weeks | Waist circumference measured in centimeters (cm) | Baseline to 24 weeks (end of treatment) |
| Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks | Waist-to-hip ratio from baseline to 24 weeks | Baseline to 24 weeks (end of treatment) |
| Mean Change in Liver Symptom Questionnaire Total Score | The Liver Symptom Questionnaire scores 10 symptoms of liver disease on a scale of 1-5. Higher scores mean higher symptom severity. Total score can range from 10-50. | Baseline to 24 weeks (end of treatment) |
| Mean Change in ALT From 24 to 48 Weeks | Change in ALT (U/L) during off treatment phase | 24 weeks (end of treatment) to 48 weeks (final study visit) |
| Mean Change in AST From 24 to 48 Weeks | AST value in U/L | 24 weeks (end of treatment) to 48 weeks (final study visit) |
| Mean Change in GGT From 24 to 48 Weeks | GGT is measured in U/L | 24 weeks (end of treatment) to 48 weeks (final study visit) |
| Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks | CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat. | 24 weeks (end of treatment) to 48 weeks (final study visit) |
| Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks | LSM is measured in kPa | 24 weeks (end of treatment) to 48 weeks (final study visit) |
| Los Angeles |
| California |
| 90089 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Indiana University- Adults | Indianapolis | Indiana | 46202 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| Lost to Follow-up |
|
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| BG002 | Vitamin E, 800 IU | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| BG003 | Placebo | matching placebo taken once daily with breakfast Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alanine Aminotransferase (ALT) | ALT value in units/liter (U/L) | Median | Inter-Quartile Range | U/L |
|
| Aspartate Aminotransferase (AST) | AST value in units/liter (U/L) | Median | Inter-Quartile Range | U/L |
|
| Liver stiffness | Fibroscan® measures liver stiffness in kiloPascal's (kPa) and ranges from 2 to 75. Normal range of FibroScan is between 2 to 7 kPa, and the average normal result is 5.3kPa. Higher kPa means more stiffness (scarring). | Median | Inter-Quartile Range | kPa |
|
| Controlled Attenuation Parameter (CAP) score | Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function. CAP is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat. | Median | Inter-Quartile Range | dB/m |
|
| OG002 | Vitamin E, 800 IU | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks |
| OG003 | Placebo | matching placebo taken once daily with breakfast Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks |
|
|
|
| Secondary | Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks | Normalization of ALT (U/L) is defined as a decrease in ALT to less than or equal to the ULN at the 24 week visit among participants who had an ALT value greater than ULN at baseline. Values for upper limits of normal (ULN) are defined at each clinical center per institutional guidelines. | Participants who completed the treatment phase of the trial (baseline to 24 weeks). Note: all participants had an ALT value greater than ULN at baseline. | Posted | Count of Participants | Participants | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline | ALT value in U/L | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | U/L | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline | AST value in U/L | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | U/L | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function | CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat. | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | dB/m | Baseline to24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan® | Fibroscan® measures stiffness in kiloPascal's (kPa) and ranges from 2 to 75. Normal range of FibroScan is between 2 to 7 kPa, and the average normal result is 5.3kPa. Higher kPa means more stiffness (scarring). | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | kPa | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks | GGT is measured in U/L | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | U/L | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Glucose From Baseline to 24 Weeks | Fasting glucose measured in mg/dL | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | mg/dL | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Weight From Baseline to 24 Weeks | Weight measured in kilograms (kg) | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | kg | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks | BMI is reported in kg/m-squared | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | kg/m-squared | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Waist Circumference From Baseline to 24 Weeks | Waist circumference measured in centimeters (cm) | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | cm | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks | Waist-to-hip ratio from baseline to 24 weeks | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | ratio | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in Liver Symptom Questionnaire Total Score | The Liver Symptom Questionnaire scores 10 symptoms of liver disease on a scale of 1-5. Higher scores mean higher symptom severity. Total score can range from 10-50. | Participants who completed the treatment phase of the trial (baseline to 24 weeks). | Posted | Mean | Standard Deviation | score difference | Baseline to 24 weeks (end of treatment) |
|
|
|
|
| Secondary | Mean Change in ALT From 24 to 48 Weeks | Change in ALT (U/L) during off treatment phase | Participants who completed the off-treatment phase of the trial (24 to 48 weeks). | Posted | Mean | Standard Deviation | U/L | 24 weeks (end of treatment) to 48 weeks (final study visit) |
|
|
|
|
| Secondary | Mean Change in AST From 24 to 48 Weeks | AST value in U/L | Participants who completed the off-treatment phase of the trial (24 to 48 weeks). | Posted | Mean | Standard Deviation | U/L | 24 weeks (end of treatment) to 48 weeks (final study visit) |
|
|
|
|
| Secondary | Mean Change in GGT From 24 to 48 Weeks | GGT is measured in U/L | Participants who completed the off-treatment phase of the trial (24 to 48 weeks). | Posted | Mean | Standard Deviation | U/L | 24 weeks (end of treatment) to 48 weeks (final study visit) |
|
|
|
|
| Secondary | Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks | CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat. | Participants who completed the off-treatment phase of the trial (24 to 48 weeks). | Posted | Mean | Standard Deviation | dB/m | 24 weeks (end of treatment) to 48 weeks (final study visit) |
|
|
|
|
| Secondary | Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks | LSM is measured in kPa | Participants who completed the off-treatment phase of the trial (24 to 48 weeks). | Posted | Mean | Standard Deviation | kPa | 24 weeks (end of treatment) to 48 weeks (final study visit) |
|
|
|
|
| 0 |
| 50 |
| 3 |
| 50 |
| 9 |
| 50 |
| EG001 | Vitamin E, 400 IU | 400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks | 0 | 51 | 2 | 51 | 10 | 51 |
| EG002 | Vitamin E, 800 IU | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks | 0 | 51 | 2 | 51 | 11 | 51 |
| EG003 | Placebo | matching placebo taken once daily with breakfast Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks | 0 | 48 | 1 | 48 | 11 | 48 |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Salivary gland infection | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Other, specify - Inflamed synovium of Right knee | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Intercranial hemorrhage | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Kidney infection | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Other, specify- gastric bypass | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Flu-like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| COVID-19 infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
| Superiority |
| Cochran-Mantel-Haenszel | 0.003 | Superiority |
| Superiority |
| ANCOVA | <0.0001 | Superiority |
| Superiority |
| ANCOVA | <0.0001 | Superiority |
| Superiority |
| ANCOVA | 0.80 | Superiority |
| Superiority |
| ANCOVA | 0.10 | Superiority |
| Superiority |
| ANCOVA | 0.35 | Superiority |
| Superiority |
| ANCOVA | 0.93 | Superiority |
| Superiority |
| ANCOVA | 0.90 | Superiority |
| Superiority |
| ANCOVA | 0.76 | Superiority |
| Superiority |
| ANCOVA | 0.05 | Superiority |
| Superiority |
| ANCOVA | 0.14 | Superiority |
| Superiority |
| ANCOVA | 0.41 | Superiority |
| Superiority |
| ANCOVA | 0.99 | Superiority |
| Superiority |
| ANCOVA | 0.39 | Superiority |
| Superiority |
| ANCOVA | 0.68 | Superiority |
| Superiority |
| ANCOVA | 0.98 | Superiority |
| Superiority |
| ANCOVA | 0.16 | Superiority |